Updated on 25 February 2013
The approval process of Xalkori in China, from the submission of the new drug application to the recent SFDA approval, took only around 11 months, as part of its inclusion in the fast approval channel of the country's Center for Drug Evaluation (CDE). "The SFDA's quick decision highlights the Chinese government's commitment to accelerate the development of new therapies that address the unmet medical needs of patients," added Dr Xiaobing.
Professor Wu Yilong, director-elect of the Chinese Society of Clinical Oncology (CSCO), Chinese Anti-Cancer Association and Director of CSCO Cancer Biomarker Expert Panel, remarked that the approval of Xalkori underscores the important role of molecular biomarkers in cancer treatment. He said, "We strongly encourage lung cancer patients to talk to their oncologists about molecular tumor testing. By fully understanding the molecular biology of their tumor, patients and physicians can make the optimal personalized treatment decisions."
Xalkori has been approved by regulatory authorities in Japan, Korea, the EU, and other markets, since it was first approved by the US FDA in August 2011. With the SFDA's approval, it is estimated that Xalkori will be made available to patients in China in the middle of this year.